Status:
UNKNOWN
AML Treatment in Untreated Adult Patients
Lead Sponsor:
Gruppo Italiano Malattie EMatologiche dell'Adulto
Conditions:
Leukemia, Myelocytic, Acute
Eligibility:
All Genders
15-61 years
Phase:
NA
Brief Summary
The present therapy intends to be an homogeneous treatment for AML patients based on a pretreatment with hydroxiurea plus an induction therapy with the standard arm with Daunorubicine as according to ...
Detailed Description
GIMEMA treatment for adult (15-60 yrs) AML patients included a 3-drug induction cycle with DNR (50 mg/m2 d 1, 3, 5), cytarabine (100 mg/m2 d1-10), etoposide (100 mg/m2 d1-5) followed by an intensive c...
Eligibility Criteria
Inclusion
- AML "de novo" with bone marrow blasts \<=30%
- Performance status: 0-3
- FAB subtype: all except M3
- Written informed consent
Exclusion
- age \<15 years and \>= 61 years
- pretreated AML with chemiotherapy (except Idrossiurea) or radiotherapy or corticosteroids for more than 7 days.
- diagnosis of acute promyelocitic leukemia (M3)
- Performance status = 4
- Uncontrolled infection
Key Trial Info
Start Date :
November 1 1998
Trial Type :
INTERVENTIONAL
End Date :
July 1 2018
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00449319
Start Date
November 1 1998
End Date
July 1 2018
Last Update
November 17 2017
Active Locations (36)
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1
Prof. Mozzana
Gallarate, Italy
2
Dr. De Blasio
Latina, Italy
3
Prof. Nalli
Lodi, Italy
4
Prof. Bordigon
Milan, Italy